Carboplatin and Etoposide With or Without Thalidomide in Treating Patients With Limited-Stage or Extensive-Stage Small Cell Lung Cancer

NCT00061919 | Completed Phase 3 DMC

• 4 other identifiers: CDR0000302440LLCG-STUDY-12EU-20207ISRCTN16174527
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy such as carboplatin and etoposide use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide in treating small cell lung cancer. PURPOSE: This randomized phase III trial is studying carboplatin, etoposide, and thalidomide to see how well they work compared to carboplatin and etoposide in treating patients with limited- or extensive-stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Survival at 2 years after study randomization

  0-2 years

Secondary Outcomes (5)

• Time to disease progression 2 years after study randomization

  0-2 years

• Toxicity as measured by NCIC CTC 3 times weekly while undergoing chemotherapy, then monthly thereafter

  Till end of treatment

• Response rates as measured by RECIST during each visit while undergoing chemotherapy and after completion of study treatment

  Till progression

• Quality of life as measured by EORTC QLQ-30 and lung-specific questionnaire(LC14) at baseline, after each course, and after completion of study treatment, and at 6, 12, 18, and 24 months after day 1 of course 1

  0-24 months

• Biological markers (measurement of VEGF, bFGF, TNF alpha, and IL-6)

  Before treatment courses 1 and 4, and then at 9 and 18 months

Study Arms (2)

Active arm (thalidomide)

EXPERIMENTAL

Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.

Drug: Carboplatin, etoposide & thalidomide

Placebo arm

PLACEBO COMPARATOR

Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.

Drug: Carboplatin, etoposide & placebo

Interventions

Carboplatin, etoposide & thalidomide DRUG

Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral thalidomide daily beginning on day 1 for up to 24 months.

Active arm (thalidomide)

Carboplatin, etoposide & placebo DRUG

Carboplatin IV on day 1 and etoposide IV on day 1 and 2 and, orally Day 3. Oral placebo daily beginning on day 1 for up to 24 months.

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed small cell lung cancer * Limited or extensive stage disease * No symptomatic brain metastases requiring immediate radiotherapy PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-3 Life expectancy * At least 8 weeks Hematopoietic * Not specified Hepatic * Not specified Renal * Ethylenediamine tetraacetic acid (EDTA) clearance greater than 60 mL/min OR * Creatinine clearance greater than 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 effective methods of contraception (including 1 highly effective method and 1 barrier method) during and for 4 weeks after study completion * No other prior malignancy within the past 3 years except nonmelanoma skin cancer or early cervical cancer * No significant medical condition or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Related Publications (1)

• Lee SM, Woll PJ, Rudd R, Ferry D, O'Brien M, Middleton G, Spiro S, James L, Ali K, Jitlal M, Hackshaw A. Anti-angiogenic therapy using thalidomide combined with chemotherapy in small cell lung cancer: a randomized, double-blind, placebo-controlled trial. J Natl Cancer Inst. 2009 Aug 5;101(15):1049-57. doi: 10.1093/jnci/djp200. Epub 2009 Jul 16.

  PMID: 19608997 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Carboplatin; Etoposide; Thalidomide

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Siow M. Lee, MD, PhD, FRCP

  University College London Hospitals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: April 1, 2003
• Primary Completion: February 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

GB (1)